MAUDE Adverse Event Report: CORDIS CASHEL OPTEASE RETRIEVAL FILTER; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number 466F220A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Unspecified Infection (1930); Perforation (2001); Perforation of Vessels (2135); Stenosis (2263)

Event Date 07/22/2005

Event Type  Injury  

Manufacturer Narrative

As reported, the patient underwent placement of an optease retrievable vena cava filter.The indication for the filter placement was not reported.At some point after the filter implantation, the patient became aware that the filter was associated with perforation and stenosis.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.Without images or procedural films for review, the reported perforation could not be confirmed and the exact cause could not be determined.It is unknown if the tilt contributed to the reported perforation.A review of the instructions for use (ifu) notes vessel damage such as intimal tears and perforation as procedural complications related to ivc filters.Perforation from removable filters is relatively common, and directly related to how long the filter has been in place.Studies have noted a greater than 80% perforation rate overall, with all filters imaged after 71 days from implantation revealing some level of perforation.Stenosis, blood clots, clotting, thrombosis and/or occlusion within the device or within the ivc and/or vasculature do not represent a device malfunction.Clinical factors that may have influenced the event include the patient¿s pre-existing comorbidities, pharmacological and lesion characteristics.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation and stenosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.

Manufacturer Narrative

Section a2 (age at the time of event, date of birth) section b3 (event date) section b5 (event description) section b7 (relevant medical history) section d1 (brand name) section d4 (model, catalog, lot number, expiration date) section d11 (concomitant medical products: micropuncture set, 0.010 guidewire, 4fr catheter, 0.035 bensen wire, optease dilator and sheath) section g4 (date received by the manufacturer) section h4 (manufacturing date) section h6 (evaluation codes: additional patient and device codes are reported) complaint conclusion: it was reported that a patient underwent placement of an optease vena cava filter.The information provided indicated that the filter subsequently malfunctioned and caused perforation and stenosis.The patient reported becoming aware of perforation, stenosis, filter embedded and unable to be retrieved and filter related infection approximately seven days post implant.The patient also reported experiencing anxiety related to the filter and a large abdominal hematoma that occurred approximately seven years post implant.There were not documented attempts to retrieve the filter reported.The indication for the filter implant was a third recurrent pulmonary embolism (pe) despite anticoagulation.The patient experienced the first pe approximately thirty-one years prior to the filter placement.The filter was placed via the right common femoral vein and was deployed within the infrarenal inferior vena cava (ivc) without complication.The patient tolerated the procedural well.Approximately 13 years and 8 months post implant, the patient underwent a computed tomography (ct) scan to evaluate the filter.Results of the scan noted that the filter is in place, the struts distend the ivc but do not definitely perforate into the surrounding soft tissue, the ivc appears to conform to the shape of the filter.The ivc caudal to the filter is narrowed, there is no evidence of perforation into the adjacent duodenum, although it is contacting the ivc and one or more of the anterior struts tangentially.A cyst on left hepatic lobe and a moderate to large hiatal hernia were also noted.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The optease retrievable vena cava filter is indicated for use in the prevention of recurrent pulmonary embolism (pe) via percutaneous placement in the inferior vena cava (ivc) for patients in which anticoagulants are contraindicated, anticoagulant therapy for thromboembolic disease has failed, emergency treatment following massive pe where anticipated benefits of conventional therapy are reduced or for chronic, recurrent pe where anticoagulant therapy has failed, or is contraindicated.The purpose of a vena cava filter is to catch thrombus from the lower extremities as it travels along normal blood flow patterns up towards the heart.The predominant concern for embedding with in the wall of the ivc is the development of endothelialization, the healing of the inner surfaces of vessels or grafts by endothelial cells.This is the normal process whereby the body heals and recovers from invasive procedures and has been shown to occur in as short a period as 12 days.Ivc filter tilt has been associated with the anatomy of the vessel, specifically asymmetry and tortuosity.Vessel perforation is a known adverse event associated with implanting vena cava filters and is listed as such in the instructions for use (ifu).The ifu also notes vessel damage such as intimal tears and perforation as procedural and long-term complications related to ivc filters.The timing and mechanism of the tilt and perforation has not been reported at this time and a clinical conclusion could not be determined.Without images available for review the events could not be confirmed or further clarified.Filter related infection was reported, however with the limited information provided a determination could not be made.Infection associated with percutaneous procedures is usually related to preparation of the patient and any underlying patient comorbidities.The patient also reported experiencing an abdominal hematoma, some years post implant, with the limited information provided it is not possible to determine what factors may have contributed to the event.Infection, hematoma and anxiety do not represent a device malfunction and may be related to underlying patient specific issues.Given the limited information available for review, there is nothing to suggest that a malfunction in the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Event Description

As reported in the legal brief, a patient underwent placement of an optease vena cava filter.The filter subsequently malfunctioned and caused injury and damage to the patient, including, but not limited to, perforation and stenosis.As a direct and proximate result of these malfunctions, the patient suffered life-threatening injuries and damages and required medical care and treatment.As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, loss of enjoyment of life, distress and other damages.The following additional information was received per implant records: the patient resented with recurrent pe while on anticoagulation therapy.The right common femoral vein was accessed and a venogram located the bilateral renal veins.Using fluoroscopic guidance, the optease filter was deployed without complication and the patient tolerated the procedure well.The following additional information was received per medical records: approximately 13 years and 8 months post implantation, the patient underwent a ct scan.Results of the scan noted that the filter is in place, the struts distend the ivc but do not definitely perforate into the surrounding soft tissue, the ivc appears to conform to the shape of the filter.The ivc caudal to the filter is narrowed, there is no evidence of perforation into the adjacent duodenum, although it is contacting the ivc and one or more of the anterior struts tangentially.A cyst on left hepatic lobe and a moderate to large hiatal hernia were also noted.The following additional information was received per patient profile form (ppf): the patient became aware of the reported events approximately (b)(4) days post implantation.The patient reports perforation of ivc filter strut(s) outside the ivc, stenosis of the ivc filter and ivc filter related infection.The patient also reports suffering from anxiety.The following additional information was received per amended patient profile form (ppf): the patient reports perforation of ivc filter strut(s) outside the ivc, filter embedded in wall of the ivc, device unable to be retrieved, stenosis of the filter and ivc filter related injury.The patient also reports suffering from anxiety.

• Brand Name: OPTEASE RETRIEVAL FILTER
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 9750109
• MDR Text Key: 188382040
• Report Number: 1016427-2020-03863
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2008
• Device Model Number: 466F220A
• Device Catalogue Number: 466F220A
• Device Lot Number: R0305432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 78 YR